<p>Post Market Surveillance and QE</p> <p>Department: Regulatory Affairs</p> <p>Reports to: Post Market Regulatory Affairs Manager</p> <p>FLSA Status: Exempt</p> <p>SUMMARY</p> <p>The Post Market Surveillance and Quality Engineer will be responsible for performing investigations related to Customer Complaints and Proactive Post Market Surveillance processes for Apyx Medical products.</p> <p>ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:</p> <ul> <li>Perform complaint investigations for Apyx Medical through close collaboration with Research and Development, Manufacturing, Sales and Marketing and other departments; Accountable for accuracy and quality of investigations; Assure that medical device incidents/complaints are documented, reviewed, investigated, trended, and reported in accordance with current procedures. </li><li>Use statistical techniques to analyze data and trends. </li><li>Conduct complex investigations, coordinate and support Failure Investigations and participate in projects related to complaint handling. </li><li>Assist in Customer Defect Tracking and Resolution to improve the overall customer experience. </li><li>Coordinate flow of returned product for proper investigation; communicate as needed with OEM customers, distributors and doctors/nurses at user facilities. </li></ul> <p>Post Market Surveillance (15%):</p> <ul> <li>Contribute to post market surveillance activities. This includes the investigation of product malfunctions, product design and/or labeling problems, as well as customer dissatisfaction issues, and the regular monitoring and reporting of post market status and metrics. Monitor metrics based on performance trends. </li><li>Perform trending and analysis as well as Post Market Surveillance activities including assisting in compiling reports for Apyx Medical products. </li></ul> <p>Process Improvement (10%):</p> <ul> <li>Work with a cross-functional team to implement robust solutions for process/device non-conformances; Monitor complaint rates and initiate improvements where required; Contribute to Feeder System metrics reviews; Support improvement initiatives; Participate directly or indirectly on project teams to develop, consolidate and/or improve complaint vigilance and related/interfacing processes and metrics. </li><li>Participate in process improvements related to complaint/adverse events by collaborating across departments; Use technical and product knowledge for accurate feedback for current product enhancements and future product development, and for escalation/awareness of issues; Liaise with R&D and New Product Introduction teams to ensure new product readiness for complaint vigilance quality process support and other functions; Support other related continuous improvement initiatives. </li></ul> <p>Other Duties as assigned (5%).</p> <p>QUALITY ASSURANCE RESPONSIBILITIES: The individual must comply with the following quality system requirements including, but not limited to:</p> <ul> <li>Use only formally approved procedures, records, documents and specifications known as "Controlled Documents" (e.g., device history records, data collection forms, drawings, procedures, and specifications). </li><li>Use only properly calibrated and maintained equipment. </li><li>Immediately bring to attention of the head of the Quality Assurance department any possible deviations from specified Standard Operating Procedures or Work Instructions he or she may notice. </li><li>Follow all Standard Operating Procedures and Work Instructions relating to the functions preformed. </li></ul> <p>Requirements</p> <p>QUALIFICATIONS</p> <p>The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities in the area of physical demands and work environment.</p> <p>EDUCATION & EXPERIENCE: Bachelor's Degree (BS) from a four-year college or university in Mechanical, Electrical, or Biomedical Engineering, or a Bachelor's Degree in Physics.</p> <p>ATTRIBUTES:</p> <ul> <li>Able to support change initiatives, develop strong effective relationships with key resources and decision makers. </li><li>Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, MDR, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations </li><li>Able to maintain up-to-date knowledge and ensure proactive compliance to FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations. </li></ul> <p>CRITICAL COMPETENCIES:</p> <ul> <li>Communication Ability: Ability to develop and articulate an effective flow of ideas and information that generates understanding and creates a climate in which others are informed and want to participate. Communicates complex concepts into everyday language. </li><li>Courage: Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Is looked at for direction in a crisis. Willing to try new ways without fear of failure. Challenges the status quo. Takes stands to resolve important issues. Energized by tough challenges. Is comfortable with change. </li><li>Analyzing & Problem-solving Skills: Use an analytical approach; evaluate a situation from varying perspectives to create well-reasoned solutions. Uses rigor and logic to solve difficult problems, provides honest analysis and looks beyond the obvious. Is able to offer options with a clear evaluation of the risk. Demonstrates continuous learning and looks for opportunities to create process improvements. </li><li>Customer & Patient Focus: This individual needs to understand company's customers and competition to maximize opportunities and advantages, and search for ways to leverage the company's current position. Advocates for patient safety and health above all else. </li><li>Results Focused: A confident individual who provides a good balance of risk taking and sound judgment in order to deliver optimal results. Is able to drive goal attainment in others with energy and focus. </li></ul> <p>LANGUAGE SKILLS: Ability to respond to common inquiries from members of the business community. Ability to effectively present information to personnel of all level employees.</p> <p>REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions.</p> <p>PHYSICAL DEMANDS</p> <p>The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</p> <p>While performing the duties of this position, the employee is regularly required to use hands to finger, handle, or feel and talk and hear. The employee frequently is required to stand, walk, sit, and reach with hands and arms. The employee is occasionally required to climb or balance and stoop, kneel, crouch or crawl. The employee may be asked to occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.</p> <p>WORK ENVIRONMENT</p> <p>The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</p> <p>While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts and risk of electric shock. The noise level in the work environment is usually moderate.</p> <p>EMPLOYMENT WITH APYX MEDICAL</p> <p>All employment with Apyx Medical is considered employment-at-will. Employment-at-will means that either party can sever the employment at any time for any reason. Additionally, the responsibilities and functions outlined in the description may be changed or modified at any time by Apyx Medical in response to its changing needs and at its sole absolute discretion.</p> <p>To apply, click the button below.</p>